W81K0223Q0132 SS DRAFT SOW.pdf

STATEMENT OF WORK FOR CORE LABORATORY QUALITY CONTROL MATERIALS

GENERAL REQUIREMENTS:

1. SCOPE OF WORK:

1.1 The contractor shall provide quality control materials listed in Table 1 in support of Madigan Army Medical Center, Joint Base Lewis McChord, WA.

1.2 The contractor shall provide the customer with a comprehensive quality control program that complies with the requirements in section 4. The contractor shall provide the customer with local administrative rights to the software. Provides customer software to meet regulations from Clinical Laboratory Improvement Amendments (CLIA) ’88 and College of American Pathologist (CAP) requirements.

1.3 The contractor shall provide software that is compatible with Data Innovations Instrument Manager

1.4 The contractor shall provide Software listed on the Defense Health Agency (DHA) Approved Products List.

1.5 The contractor shall provide lot reserves for 12 months or longer for high volume controls.

The Contractor shall perform to the standards of this Statement of Work (SOW).

2. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

2.1. GENERAL. None.

3. SPECIFIC TASKS:

3.1. DESCRIPTION: The Contractor shall provide quality control materials in Table 1 (including all quality control materials, software, support, licenses).

3.1.1 The software shall be capable of interfacing with the Data Innovations Instrument Manager (DIIM).

The Contractor shall have an established driver compatible for interfacing the analyzer with DIIM.

3.1.2 The Contractor shall provide the quality control materials and shall coordinate exact quantities and shipment schedule with the Designated Government Point of Contact prior to shipment IAW Paragraph 3.2.3 Deliveries (below).

3.1.3. The Contractor shall provide peer data review software and include any cost to maintain access to the software through the lifecycle of the contract.

3.2 QUALITY CONTROL MATERIALS.

All assays shall be FDA approved.

TABLE 1 Required Quality control materials

QUALITY CONTROL MATERIAL

Unassayed Chemistry Controls

Ethanol/ Ammonia Controls Automated Urinalysis Controls

Manual Urinalysis Controls Immunoassay Controls

Rubella Controls Tumor Marker Controls

Urine Chemistry Controls Hepatitis Controls Cardiac Controls

Immunology Controls Spinal Fluid Controls

Pediatric Controls Diabetic Controls

SARS-CoV2 Controls Special Immunoassay Controls

3.2.1 The manufacturer will sequester the required quality control materials to ensure that no more than one lot change occurs per contract year.

3.2.2 All quality control material provided will be identical to those used in the FDA 510K approval application. All quality control materials will be provided as follows:

3.2.2.1 Be provided by a single manufacturer.

3.2.2.2 Be marked with the required storage temperature.

3.2.2.3 Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

3.2.2.4 Quality control material will be ready to use and not require reconstitution unless prior approval is given by the customer.

3.2.2.5 All deliverable shall be liquid ready and not require reconstitution. If liquid ready quality control is not available, lyophilized quality control shall be approved by the Designated Government Point of Contact.

3.2.3 Deliveries of required items will be per monthly periodic orders called or emailed in to the Contractor by the designated Government Point of Contract or others as identified in the contract. Orders shall be delivered to the delivery location identified within 7 calendar days from order placement. The quantities identified by order shall not exceed the amount identified by the corresponding CLIN of the contract.

4. INFORMATION MANAGEMENT.

4.1 The quality control software shall be capable of interfacing with the Data Innovations Instrument Manager (DIIM). The Contractor shall have an established driver compatible for interfacing the analyzer with

DIIM.

4.2 The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

4.3 The QC software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager for autoverification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4.4 The software shall be the most up to date version of software (i.e. Windows 10) that has the most current security upgrades and security patches.

4.5 The Contractor shall provide local administrative rights to the government in order to manage the software.

4.6 The software shall be compatible with all Core Laboratory Instrumentation to include, but not limited to Cobas 8000, Osmo1 Osmometer, Medtox ScanReader, Quidel Sofia, Diagnostica Stago, Alifax Roller 20.

4.7 The software shall be able to allow the government user to add 3rd party quality control files to software.